COr Loco-regional Advanced Lung Cancer Treated With Chemo-radiotherapy (COLA)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chemoradiotherapy.
- Who it may be relevant to
- Registry conditions: Cardiac Toxicity, Lung Cancer Stage III, Lung Cancer Stage II, Radiation Toxicity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Radiotherapy on the Heart in Loco-regional Advanced NSCLC Patients Treated With Definitive Radiotherapy Measured by Cardiac MR
Overview
Patients with loco-regional NSCLC planned for curative treatment with chemoradiotherapy will be invited to participate in a prospective study; besides routine treatment, the patients will be followed with an ECG and cardiac MR for at least two years after radiotherapy treatment.
Detailed description
Definitive chemo-radiotherapy is the treatment of choice for loco-regional advanced non-small cell lung cancer (LA-NSCLC). However, the treatment is associated with a range of side effects with radiation pneumonitis and esophagitis. In addition, the toxicity of the heart in lung cancer patients treated with radiotherapy has been offered less consideration. Therefore, it is essential to investigate the possible early and late toxicity to the heart and the baseline cardiac status of these patients. This study will describe cardiac comorbidity before radiotherapy treatment by a thorough history. Furthermore, we will evaluate heart function and evaluate possible heart disease by an ECG and cardiac MR. Patients will be followed with ECG and cardiac MR for two years after radiotherapy, detecting structural changes caused by radiotherapy and subclinical disease after radiotherapy.
Interventions
- Other Chemoradiotherapy
Cardiac Magnetic Resonance scan and ECG
Primary outcome measures
- Overall survival [Time frame: 2 Years]
- Change in Left Ventricular Ejection Fraction [Time frame: Baseline, at 6, 12 and 24 months.]
- Number of participants with treatment related adverse events and cardiac disease after radiotherapy as assesed by CTCAE v4.0. [Time frame: 2 years.]
- Cardiovascular specific mortality [Time frame: 2 years.]
Secondary outcome measures (4)
- Late enhacment [Time frame: At Baseline, 6, 12 and 24 months.]
- LVEDV changes [Time frame: 2 years]
- LVESV changes [Time frame: 2 years]
- LV mass in gram [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 Years
- Inoperable and histologically/cytologically verified NSCLC.
- Planned treatment with curative intent.
- Capable of completing study procedures ECG and Cardiac MR.
- Able of giving written and informed consent before study procedures are initiated.
Exclusion criteria
- Vulnerable patients.
- Patients with operable devices as pacemaker/ICD and cochlear implant or other conditions where MR scan is contraindicated.
- Claustrophobia.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Odense University Hospital — Odense C
Identifiers
NCT: NCT05258448 · S-20160086